BMX-502 / Biomunex, Ipsen - LARVOL DELTA

Biomunex to Present Preclinical Data of its MAIT Engager Platform in Immuno-Oncology at 2025 SITC Annual Meeting (Businesswire) - "The presentation at SITC Annual meeting will focus on the MAIT engager differentiation from classical CD3+ TCEs and highlight the superior safety of MAIT engagers....With a very attractive safety and efficacy profile, MAIT engagers have a major potential to fuel an innovative portfolio of drug candidates in oncology....Based on preclinical data, Biomunex expects the first MAIT engager to enter clinical trials soon."

New trial • Preclinical • Oncology

The MAIT Engager platform: Rapid generation of several MAIT T-cell engagers with significantly improved safety profile and large therapeutic window. (SITC 2025) - "In addition, MAIT engagers do not activate regulatory T-cells and so will not increase local immunosuppression in the tumor microenvironment. Taken together, MAIT engagers are expected to increase the efficacy ratio with a significantly improved safety profile and large therapeutic window for the treatment of solid tumors."

Clinical • Oncology • Ovarian Cancer • Solid Tumor • CD4 • CD8 • GPC3 • HER-2 • IL10 • IL6 • MSLN

The MAIT Engager platform: Rapid generation of several MAIT T-cell engagers with significantly improved safety profile and large therapeutic window (SITC 2025) - "In addition, MAIT engagers do not activate regulatory T-cells and so will not increase local immunosuppression in the tumor microenvironment. Taken together, MAIT engagers are expected to increase the efficacy ratio with a significantly improved safety profile and large therapeutic window for the treatment of solid tumors."

Clinical • Oncology • Ovarian Cancer • Solid Tumor • CD4 • CD8 • GPC3 • HER-2 • IL10 • IL6 • MSLN

MAIT engagers: Providing a large therapeutic window for the treatment of solid tumors (AACR 2025) - "MAIT cell engagers are a promising approach for the treatment of solid tumors that have the potency and efficacy of a classical TCE but with a significantly improved cytokine safety profile leading to a larger therapeutic window."

Oncology • Ovarian Cancer • Solid Tumor • CD4 • CD8 • HER-2

Ipsen and Biomunex announce exclusive global licensing agreement for first-in-class MAIT cell engager in immuno-oncology (GlobeNewswire) - "Ipsen...and Biomunex Pharmaceuticals...announced an exclusive global licensing agreement for BMX-502....Under the terms of the agreement, Biomunex will complete the IND-enabling package. Ipsen will assume responsibility for Phase I preparation activities, including submission of the Investigational New Drug (IND) application, and all subsequent clinical-development and global commercialization activities. Biomunex is eligible to receive up to $610 million, including upfront, contingent upon successful development, regulatory and commercial milestones, in addition to tiered global royalties on sales."

Licensing / partnership • Solid Tumor

MAIT engagers: Bispecific antibody-mediated redirection of mucosal associated invariant T cells to treat solid tumors (AACR 2024) - "Ex vivo cytotoxicity of tumor-resident MAIT cells using dissociated ovarian cancer samples at "real E:T ratios", MAIT engager-mediated cytotoxicity of patient-derived organoids (CRC) and in vivo evaluation of tumor control will be shown.Conclusions. MAIT cell redirection is a promising approach for the treatment of solid tumors that has the potency and efficacy of a classical TCE but with a significantly improved cytokine safety profile leading to a larger therapeutic window."

Hematological Malignancies • Oncology • Ovarian Cancer • Solid Tumor • CD4 • CD8 • HER-2

BiXAb® MAIT Engagers: solving the problems of classical T-cell engagers in the treatment of solid tumors (SITC 2023) - "Ex vivo cytotoxicity of tumor-resident MAIT cells using freshly isolated ovarian tumor material and MAIT engager-mediated cytotoxicity of patient derived organoids (Colorectal cancer) will be shown. Conclusions The tissue/tumor abundance and potent cytotoxic capability of MAIT cells and the specificity of MAIT engagers (no activation of CD4s/Tregs: reduced CRS and immunosuppression) strongly support the contention that MAIT engagers would have a major, durable response in the treatment of solid tumors."

Colorectal Cancer • Gastrointestinal Cancer • Hematological Malignancies • Oncology • Ovarian Cancer • Solid Tumor • CD4 • CD8 • HER-2

MAIT Engagers: BiXAb-Mediated Redirection of MAIT Cells to Efficiently Kill Tumors (IO-SUMMIT EUROPE 2023) - "BiXAb-mediated engagement of MAITs (via the unique TCR) and a cancer cell (via a tumor-associated antigen) leads to efficient killing of the tumor cells. This modality does not induce activation of general T cell subsets, in contrast to classical T cell engagers, and promises to significantly impact solid tumors."

Oncology • Solid Tumor

MAIT engagers: An efficacious novel modality in the field of T-cell engagers for the treatment of solid tumors (AACR 2023) - "BiXAb® mediated MAIT cell redirection leads to efficient killing of cancer cells and is a promising new approach for the treatment of solid tumors. The iTCR x HER2 BiXAb® has no impact on the general CD8 or CD4 T-cell population which may address some of the clinical limitations of classical TCEs."

Hematological Malignancies • Oncology • Solid Tumor • CD4 • CD8 • HER-2